This is a phase 1/1b study of TTX-030, an antibody that inhibits CD39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (ATP) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. This trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of TTX-030 as a single agent and in combination with an approved anti-PD-1 immunotherapy and standard chemotherapies.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | April 10, 2019 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Recommended Phase 2 Dose (RP2D)
Primary Outcome 1 - Time Frame: 1 cycle (each cycle is 21-28 days)
Criteria:
Abreviated Inclusion Criteria
1. Advanced solid tumor malignancy or relapsed/refractory lymphoma, or
- eligible to receive single-agent pembrolizumab as standard of care, or
- eligible to receive single-agent docetaxel as standard of care, or
- advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus
nab-paclitaxel as standard of care.
2. Age 18 years or older, is willing and able to provide informed consent
3. Evidence of measurable disease
4. Life expectancy > 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance
status of 0-1
Abbreviated Exclusion Criteria
1. History of allergy or hypersensitivity to study treatment components. Patients with a
history of severe hypersensitivity reaction to any monoclonal antibody.
2. Use of investigational agent within 28 days prior to the first dose of study treatment
and throughout the study
3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive
therapy
4. History of severe autoimmune disease
5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing
treatment
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Anthony Tolcher, MD
Role: Principal Investigator
Affiliation: NEXT Oncology
Name: Tizona Therapeutics, Inc.
Phone: 888-585-2990
Email: clinicaltrials@tizonatx.com
Facility | Status | Contact |
---|---|---|
Sylvester Comprehensive Cancer Center Miami, Florida 33136 United States |
Recruiting |
Reisy Guedes 305-243-8807 rxg957@med.miami.edu |
West Cancer Center and Research Institute Germantown, Tennessee 38138 United States |
Recruiting |
Amanda Fletcher 901-683-0055 afletcher@westclinic.com |
Sarah Cannon Research Institute Nashville, Tennessee 37203 United States |
Recruiting |
Referral Line 615-329-7478 Cann.researchreferrals@scresearch.net |
NEXT Oncology San Antonio, Texas 78229 United States |
Recruiting |
Sarah Gomez 210-580-9521 sgomez@nextsat.com |
Hunstman Cancer Intitute Salt Lake City, Utah 84112 United States |
Recruiting |
Hannah Conway 801-587-4021 hannah.conway@hci.utah.edu |